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Seeking Biotech Alpha DECEMBER 2019 Insight

LYNPARZA® (olaparib)

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LYNPARZA (Olaparib) Approved in the US as a 1st-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic Cancer

Mon December 30, 2019 6:55 AM|Business Wire|About: AZN

LYNPARZA reduced the risk of disease progression or death by 47% in patients whose disease had not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen 
Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)


 https://www.businesswire.com/news/home/20191230005085/en/ 


 https://www.astrazeneca-us.com/ 


 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-approved-in-the-us-as-a-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer-30122019.html 



AZD0466 (DEP® Bcl2/xL conjugate)

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 h 

Starpharma: Commencement of Phase 1 Trial for AZD0466 Utilising DEP® Delivery Technology

Sun December 29, 2019 6:07 PM|Business Wire|About: AZN, SPHRY

  • AstraZeneca has commenced its first-in-human/phase 1 clinical trial for AZD0466 in the US in a range of cancers
  • AZD0466 utilises Starpharma’s proprietary DEP® delivery technology and is a highly optimised nanomedicine formulation of a novel dual Bcl2/xL inhibitor
  • US$3 million milestone payment to Starpharma (SPHRY) has been triggered by the first dose of AZD0466 administered in the trial under its multi-product DEP® licence with AstraZeneca

MELBOURNE, Australia--(BUSINESS WIRE)-- Starpharma today announced that AstraZeneca (AZN)


 https://www.businesswire.com/news/home/20191229005009/en/ 


 https://seekingalpha.com/symbol/SPHRY 


 

Dec 30, 2019

Commencement of phase 1 trial for AZD0466 utilising DEP®

 https://www.starpharma.com/news/story/commencement-of-phase-1-trial-for-azd0466-utilising-dep 

selpercatinib, LOXO-292

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Lilly Opens Phase 3 Clinical Trial in RET-Mutant Medullary Thyroid Cancer

Mon December 30, 2019 6:45 AM|PR Newswire|About: LLY

- Randomized trial will examine selpercatinib against standard of care in 400 patients with advanced or metastatic treatment-naïve RET-mutant medullary thyroid cancer

PR Newswire

INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) today announced the opening of the LIBRETTO-531 clinical trial [NCT04211337] for selpercatinib, also known as LOXO-292


 https://www.prnewswire.com/news-releases/lilly-opens-phase-3-clinical-trial-in-ret-mutant-medullary-thyroid-cancer-300979626.html 


 https://www.lillyoncology.com/ 



VASCEPA® (ICOSAPENT ETHYL)

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HLS Therapeutics Announces Health Canada Approval for Vascepa® to Reduce the Risk of Cardiovascular Events

Tue December 31, 2019 1:00 PM|Canada Newswire|About: AMRN, HLTRF

  • Health Canada approval follows priority review for Vascepa

  • Vascepa becomes the first and only HC-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for treatment

  • Commercial launch expected to take place in the mid-February 2020 timeframe

  • Vascepa is supported by data from the REDUCE-IT® trial, an international, 8,179 patient outcomes study that showed a 25% placebo-controlled risk reduction in the first occurrence of major adverse cardiovascular events

  • Vascepa is the subject of numerous Canadian issued and pending patents with expiration dates which could extend to 2039.

TORONTO, Dec. 31, 2019 /CNW/ - HLS Therapeutics Inc. (HLTRF) ("HLS" or the "Company") (TSX:HLS)


 

CV benefit claim for Amarin's Vascepa OK'd in Canada; shares up 3%

Dec. 31, 2019 1:17 PM ET|About: Amarin Corporation plc (AMRN)|By: , SA News Editor 

 https://seekingalpha.com/news/3528971-cv-benefit-claim-for-amarins-vascepa-okd-in-canada-shares-up-3 


 https://amarincorp.com/products.html 

Alimta® (pemetrexed for injection) vitamin regimen patent

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U.S. District Court Rules in Favor of Lilly in Alimta Vitamin Regimen Patent Lawsuit

Mon December 30, 2019 1:09 PM|PR Newswire|About: LLY 

 INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY


 

U.S. District Court Rules in Favor of Lilly in Alimta Vitamin Regimen Patent Lawsuit

12/30/2019Download PDF

INDIANAPOLIS, Dec. 30, 2019 /PRNewswire/ -- Eli Lilly and Company

 https://investor.lilly.com/news-releases/news-release-details/us-district-court-rules-favor-lilly-alimta-vitamin-regimen-0 


 https://www.prnewswire.com/news-releases/us-district-court-rules-in-favor-of-lilly-in-alimta-vitamin-regimen-patent-lawsuit-300979927.html 


What Is ALIMTA® (pemetrexed for injection) Approved For? ALIMTA® (pemetrexed for injection) is approved by the FDA in combination with KEYTRUDA® (pembrolizumab) (an immunotherapy) and platinum chemotherapy (carboplatin or cisplatin, two other chemotherapy drugs) as the first treatment for nonsquamous non-small cell lung cancer (NSCLC) that has spread with no abnormal EGFR or ALK gene.* ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the first (initial) treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC that has spread. ALIMTA is approved by the FDA as a single agent (used alone) for maintenance treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after you have received 4 cycles of chemotherapy that contains platinum for first treatment and your cancer has not progressed. ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with recurrent, metastatic nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, which has returned or spread after prior chemotherapy. ALIMTA is not appropriate for people who have a different type of NSCLC called squamous cell. *Epidermal growth factor receptor (EGFR) is a tumor marker found in some people with nonsquamous NSCLC. It is found on both normal and tumor cells and is important for cell growth. Anaplastic lymphoma kinase (ALK) is a protein that may be involved in cell growth. Changes to the ALK gene have been found in some types of cancer, including nonsquamous NSCLC.

Valoctocogene Roxaparvovec

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BioMarin Announces New England Journal of Medicine Publishes 3 Years of Follow-up Data in Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A

Thu January 2, 2020 8:31 AM|PR Newswire|About: BMRN

Completely Eliminated Prophylactic Factor VIII Use in 6e13 vg/kg and 4e13 vg/kg Doses

2nd Publication in NEJM on Valoctocogene Roxaparvovec

PR Newswire

SAN RAFAEL, Calif., Jan. 2, 2020 /PRNewswire/ --BioMarin Pharmaceutical Inc. (BMRN)


 https://www.prnewswire.com/news-releases/biomarin-announces-new-england-journal-of-medicine-publishes-3-years-of-follow-up-data-in-phase-12-study-of-valoctocogene-roxaparvovec-gene-therapy-for-hemophilia-a-300980377.html 

Seeking Biotech Alpha DECEMBER 2019 Insight

REVLIMID® (lenalidomide)

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID® in Relapsed or Refractory Indolent Lymphoma

Sun December 22, 2019 6:00 PM|GlobeNewswire|About: BGNE

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)


 https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal 


 https://media2.celgene.com/content/uploads/revlimid-pi.pdf 


 http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-0?loc=US 

SRP-9001 (AAVrh74.MHCK7.micro-dystrophin)

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Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy for Duchenne Muscular Dystrophy, SRP-9001

Mon December 23, 2019 1:00 AM|GlobeNewswire|About: SRPT

Roche obtains the exclusive right to launch and commercialize SRP-9001 outside the United States

At closing, Sarepta will receive an upfront payment of $1.15 billion, comprising $750 million in cash and $400 million in Sarepta stock, priced at $158.59 per share of common stock –  

Additionally, Sarepta is eligible to receive up to $1.7 billion in regulatory and sales milestones, plus royalties on net sales

Sarepta will continue to be responsible for clinical development and manufacturing of SRP-9001 with global clinical development costs shared equally with Roche

Sarepta will host a conference call on Monday, Dec. 23 at 08:30 a.m. ET

CAMBRIDGE, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)


 https://www.sarepta.com/our-pipeline 



UBRELVYTM (ubrogepant)

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Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults

Mon December 23, 2019 3:13 PM|PR Newswire|About: AGN

-- With just one dose, UBRELVY™ can quickly eliminate patients' migraine pain and their most bothersome migraine symptom compared with placebo at two hours --

-- Pain freedom (or elimination of pain) is a recent, more stringent standard of efficacy set forth by the FDA for acute treatment of migraine --

-- UBRELVY™ demonstrated low rates of side effects in clinical trials --

PR Newswire

DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (AGN


 https://media.allergan.com/products/Ubrelvy_pi.pdf 


 https://www.prnewswire.com/news-releases/allergan-receives-us-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults-300979082.html 


 http://www.ubrelvy.com/ 


 

Allergan gets FDA approval for oral migraine treatment

Dec. 23, 2019 3:23 PM ET|About: Allergan plc (AGN)|By: , SA News Editor  

 https://seekingalpha.com/news/3528262-allergan-gets-fda-approval-for-oral-migraine-treatment 

Tremfya (guselkumab)

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 DECEMBER 27, 2019 / 3:02 AM / UPDATED 5 HOURS AGO

China regulator approves imports of J&J's Tremfya

 BEIJING (Reuters) - China has approved imports of Johnson & Johnson’s Tremfya (guselkumab) 


 

Johnson & Johnson's Tremfya gets China approval

Dec. 27, 2019 7:36 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3528535-johnson-johnsons-tremfya-gets-china-approval 

Tislelizumab

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China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Classical Hodgkin’s Lymphoma Who Have Received at Least Two Prior Therapies

Fri December 27, 2019 10:30 PM|GlobeNewswire|About: BGNE

  • Second BeiGene (BGNE)-discovered drug to receive regulatory approval, first in China

  • Tislelizumab is an anti–PD-1 antibody specifically designed to minimize binding to FcγR on macrophages

BEIJING, China and CAMBRIDGE, Mass., Dec. 27, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd.,


 https://www.beigene.com/science-and-product-portfolio/pipeline 


 

Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies,

 https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab 

Seeking Biotech Alpha DECEMBER 2019 Insight

ERVEBO® (Ebola Zaire Vaccine, Live)

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First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

Thu December 19, 2019 7:25 PM|PR Newswire 

 

FDA OKs Merck Ebola vaccine

Dec. 19, 2019 10:04 PM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor  

 https://seekingalpha.com/news/3527618-fda-oks-merck-ebola-vaccine 


 

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Fri December 20, 2019 7:15 AM|Business Wire|About: MRK 

 https://seekingalpha.com/pr/17734317-merck-announces-fda-approval-for-ervebo-ebola-zaire-vaccine-live 


 https://www.merck.com/index.html 



KEYTRUDA® (pembrolizumab)

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Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

Fri December 20, 2019 6:45 AM|Business Wire|About: MRK

KEYTRUDA Now Approved for Six Cancer Types Plus Microsatellite Instability-High (MSI-H) Tumors in Japan

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)


 https://www.merck.com/clinical-trials/index.html 


 https://www.businesswire.com/news/home/20191220005101/en/ 


 

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

KEYTRUDA Now Approved for Six Cancer Types Plus Microsatellite Instability-High (MSI-H) Tumors in Japan

Friday, December 20, 2019 6:45 am EST 


 https://www.merck.com/index.html 



 https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-approved-japan-three-new-first-line-indications- 

 

New indications for Merck's Keytruda OK'd in Japan

Dec. 20, 2019 6:51 AM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor  

 https://seekingalpha.com/news/3527675-new-indications-for-mercks-keytruda-okd-in-japan 

Revlimid® (lenalidomide) in Combination with Rituximab

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Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

Fri December 20, 2019 6:59 AM|Business Wire|About: BMY

Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

Approval was based on data from the phase 3 AUGMENT study, which showed statistically significant improvements in median progression-free survival in patients treated with the combination over rituximab-placebo monotherapy

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://www.businesswire.com/news/home/20191220005238/en/ 


 https://www.rituxan.com/ 


 https://www.revlimid.com/ 


 

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

Approval was based on data from the phase 3 AUGMENT study, which showed statistically significant improvements in median progression-free survival in patients treated with the combination over rituximab-placebo monotherapy

CATEGORY: 

CORPORATE/FINANCIAL NEWSFRIDAY, DECEMBER 20, 2019 6:59 AM EST 

 https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-european-commission-approval-rev 

Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir)

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China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment

Fri December 20, 2019 8:30 AM|Business Wire|About: GILD

– Vosevi Provides a New Option for People with HCV Who Have Not Achieved Cure with Prior Direct-Acting Antiviral Treatment –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.businesswire.com/news/home/20191220005282/en/ 


 https://www.vosevi.com/ 


December 20, 2019

China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment

 https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/china-national-medical-products-administration-approves-vosevi-sofosbuvir-velpatasvir-and-voxilaprevir-for-people-with-chronic-hepatitis-c-infecti 

ENHERTU (fam-trastuzumab deruxtecan-nxki)

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ENHERTU (fam-trastuzumab deruxtecan-nxki) Approved in the US for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens

Fri December 20, 2019 6:04 PM|Business Wire|About: AZN

Accelerated Approval of AstraZeneca and Daiichi Sankyo’s ENHERTU based on the DESTINY-Breast01 trial that showed clinically meaningful and durable responses

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Daiichi Sankyo Company, Limited (Daiichi Sankyo) 


 http://www.enhertupi.com/ 


 https://seekingalpha.com/pr/17734865-fda-approves-new-treatment-option-for-patients-her2-positive-breast-cancer-who-progressed-on 


 http://www.enhertupi.com/ 


 https://www.businesswire.com/news/home/20191220005575/en/ 

J & J Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

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Johnson & Johnson Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer

Fri December 20, 2019 4:01 PM|PR NewswirePR Newswire

NEW BRUNSWICK, N.J., Dec. 20, 2019 /PRNewswire/ -- Johnson & Johnson announced today the acquisition of TARIS Biomedical LLC (TARIS)


 https://www.janssen.com/ 


 https://tarisbiomedical.com/ 


 https://www.prnewswire.com/news-releases/johnson--johnson-acquires-taris-biomedical-with-focus-on-transforming-the-treatment-of-bladder-cancer-300978469.html 


 https://tarisbiomedical.com/pipeline/ 

Seeking Biotech Alpha DECEMBER 2019 Insight

SPRAVATO™ (Esketamine) Nasal Spray

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BUSINESS WIRE

 

SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder

BEERSE, Belgium   19DEC2019 


 

J&J's Spravato OK'd in Europe for treatment-resistant depression

Dec. 19, 2019 6:35 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3527331-j-and-js-spravato-okd-in-europe-for-treatment-resistant-depression 

PADCEV™ (enfortumab vedotin-ejfv)

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FDA Grants Accelerated Approval to Astellas' and Seattle Genetics' PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer

Wed December 18, 2019 7:49 PM|PR Newswire|About: ALPMY, SGEN

- PADCEV is the First Treatment Approved for Locally Advanced or Metastatic Urothelial Cancer Following Treatment with Platinum-based Chemotherapy and a PD-1 or PD-L1 Inhibitor -

PR Newswire

TOKYO and BOTHELL, Wash., Dec. 18, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (SGEN)


 https://www.prnewswire.com/news-releases/fda-grants-accelerated-approval-to-astellas-and-seattle-genetics-padcev-enfortumab-vedotin-ejfv-for-people-with-locally-advanced-or-metastatic-urothelial-cancer-the-most-common-type-of-bladder-cancer-300977283.html 


 

Seattle Genetics to Host Conference Call and Webcast on December 19, 2019 to Discuss PADCEVTM(enfortumab vedotin-ejfv) Approval

12/18/2019

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) will host a conference call and webcast on Thursday, December 19, 2019 to discuss the U.S. Food and Drug Administration approval of PADCEVTM (enfortumab vedotin-ejfv). 

 https://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-to-Host-Conference-Call-and-Webcast-on-December-19-2019-to-Discuss-PADCEVTM-enfortumab-vedotin-ejfv-Approval/default.aspx 


 https://www.astellas.com/us/innovation/r-and-d 


 https://www.fda.gov/news-events/press-announcements/fda-approves-new-type-therapy-treat-advanced-urothelial-cancer 

Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

 

Catalyst Biosciences Announces Global License and Collaboration Agreement to Develop Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

Thu December 19, 2019 8:00 AM|GlobeNewswire|About: BIIB, CBIOGlobeNewswire

SOUTH SAN FRANCISCO, Calif., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO)


 https://www.catalystbiosciences.com/ 


 http://ir.catalystbiosciences.com/events-and-presentations/upcoming-events?c=254141&p=irol-calendar 


 https://seekingalpha.com/symbol/CBIO 



filgotinib, an investigational, oral, selective JAK1 inhibitor

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Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

Thu December 19, 2019 4:30 PM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.businesswire.com/news/home/20191219005768/en/ 


 

December 19, 2019

Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

 https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/gilead-submits-filgotinib-new-drug-application-to-us-food-and-drug-administration-under-priority-review-for-rheumatoid-arthritis-treatment 


ABP 798, Biosimilar Candidate To Rituxan® (rituximab)

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Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration

Thu December 19, 2019 4:44 PM|PR Newswire|About: AGN, AMGNPR Newswire

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ -- Amgen (AMGN) and Allergan plc (AGN). (NYSE:AGN)


 

Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration

Filing for ABP 798 Supported by Two Comparative Clinical Studies

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN)

 https://www.amgen.com/media/news-releases/2019/12/amgen-and-allergan-submit-biologics-license-application-for-abp-798-biosimilar-candidate-to-rituxan-rituximab-to-us-food-and-drug-administration/ 


 https://www.allergan.com/ 


 https://www.prnewswire.com/news-releases/amgen-and-allergan-submit-biologics-license-application-for-abp-798-biosimilar-candidate-to-rituxan-rituximab-to-us-food-and-drug-administration-300978011.html 

VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%)

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Bausch + Lomb Announces VYZULTA® (Latanoprostene Bunod Ophthalmic Solution 0.024%) Now Publicly Covered Under the Ontario Public Drug Benefit (ODB) Program

Thu December 19, 2019 4:01 PM|Canada Newswire|About: BHC

LAVAL, QC, Dec. 19, 2019 /CNW Telbec/ - Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (BHC) (TSX: BHC)


 https://www.formulary.health.gov.on.ca/formulary/ 


 https://www.bausch.ca/en-ca/ 


 https://www.bauschhealth.ca/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

RINVOQ™ (upadacitinib)

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AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Wed December 18, 2019 10:50 AM|PR Newswire|About: ABBV

- In five pivotal Phase 3 studies, RINVOQ™(upadacitinib) met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis[1-6]

- RINVOQ, given alone or with csDMARDs, demonstrated improved rates of low disease activity (DAS28-CRP≤3.2) and clinical remission (DAS28-CRP<2.6) compared to placebo, MTX or adalimumab[1-6]

- Nearly 3 million people in Europe are living with rheumatoid arthritis, the majority of whom don't achieve remission[7,8]

PR Newswire

NORTH CHICAGO, Ill., Dec. 18, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.ema.europa.eu/en 

 https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-rinvoq-upadacitinib-for-treatment-adults-with-moderate-to-severe-active-rheumatoid-arthritis.htm 


 https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-rinvoq-upadacitinib-for-the-treatment-of-adults-with-moderate-to-severe-active-rheumatoid-arthritis-300976990.html 


Tucatinib in combination with trastuzumab and capecitabine

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Seattle Genetics Announces U.S. FDA Grants Breakthrough Therapy Designation for Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer

Wed December 18, 2019 8:00 AM|Business Wire|About: SGEN

- Designation Based on Positive Pivotal HER2CLIMB Trial Evaluating Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer; Data were Presented at 2019 SABCS and Published in the New England Journal of Medicine -

- New Drug Application Submission to U.S. FDA Expected by First Quarter of 2020 -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN)


 https://clinicaltrials.gov/ct2/show/NCT03975647?term=tucatinib&draw=3 


 https://www.seattlegenetics.com/ 


 Tucatinib is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, colorectal, and gastric cancers. Between 15% and 20% of breast cancers cases worldwide are HER2-positive. 

 https://www.seattlegenetics.com/pipeline/tucatinib 


 https://www.businesswire.com/news/home/20191218005170/en/ 


 

Seattle Genetics' tucatinib nabs accelerated review in U.S. for HER2+ breast cancer

Dec. 18, 2019 10:26 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: , SA News Editor  

 https://seekingalpha.com/news/3527131-seattle-genetics-tucatinib-nabs-accelerated-review-in-u-s-for-her2-breast-cancer 

VENCLEXTA® With Rituximab

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AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia (CLL)

Wed December 18, 2019 2:56 PM|Canada Newswire|About: ABBV

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA)i, Quebec is the first province to reimburse the combination treatment.
  • VENCLEXTA® + rituximab is a regimen that includes a targeted oral agent that should be continued for two years after initial five weeks ramp-up phase.

MONTREAL, Dec. 18, 2019 /CNW/ - AbbVie (ABBV)


 http://www.abbvie.ca/ 


 http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf 


 

RITUXAN® (rituximab) is a prescription medicine used to treat adults with:

  • Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
  • Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.

 https://www.rituxan.com/patient/what-is-rituxan.html 


VENCLEXTA is a prescription medicine used:

  • to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
    • are 75 years of age or older, or
    • have other medical conditions that prevent the use of standard chemotherapy.

VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.

 https://www.venclexta.com/ 


CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

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Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA

Wed December 18, 2019 4:16 PM|Business Wire|About: BMY

BLA submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://www.businesswire.com/news/home/20191218005737/en/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

LYNPARZA® (olaparib)

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LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Tue December 17, 2019 2:09 PM|Business Wire|About: MRK

Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada,


 https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1 


 https://www.merck.com/clinical-trials/index.html 

 https://www.merck.com/index.html 


 https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-recommended-fda-advisory-committee-first-line-maintenance-th 


 https://www.businesswire.com/news/home/20191217005774/en/ 



Acthar® Gel (Repository Corticotropin Injection) for Severe Keratitis

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First Patient Enrolled in Mallinckrodt Phase 4 Trial of Acthar® Gel (Repository Corticotropin Injection) for Severe Keratitis

Mon December 16, 2019 4:45 PM|PR Newswire|About: MNK

STAINES-UPON-THAMES, United Kingdom, Dec. 16, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK),


 https://clinicaltrials.gov/ct2/show/NCT03656692?term=acthar&cond=Uveitis&rank=4 


 https://www.acthar.com/pdf/Acthar-PI.pdf 


 https://www.prnewswire.com/news-releases/first-patient-enrolled-in-mallinckrodt-phase-4-trial-of-acthar-gel-repository-corticotropin-injection-for-severe-keratitis-300975529.html 

Kadcyla (trastuzumab emtansine)

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European advisory group backs expanded use of Roche's Kadcyla

Nov. 15, 2019 7:38 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor 


 

Roche's Kadcyla OK's in Europe for adjuvant treatment of HER+ breast cancer

Dec. 19, 2019 6:47 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor 

 https://seekingalpha.com/news/3527336-roches-kadcyla-oks-in-europe-for-adjuvant-treatment-of-breast-cancer 


 

European Commission approves Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

  • Kadcyla in early breast cancer represents a new option after neoadjuvant treatment for this group of patients who are known to have a worse prognosis
  • Approval based on KATHERINE trial data showing Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant setting

Basel, 19 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) 

 https://www.roche.com/media/releases/med-cor-2019-12-19.htm 

Lynparza (olaparib)

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FDA advisory committee backs AstraZeneca's Lynparza for pancreatic cancer

Dec. 17, 2019 4:53 PM ET|About: AstraZeneca PLC (AZN)|By: , SA News Edito 


 

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

PUBLISHED17 December 2019

17 December 2019 18:00 GMT
 

ODAC voted that Lynparza demonstrated a clinically meaningful and favourable
risk-benefit profile for patients based on Phase III POLO trial results

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html 

DCR-A1AT for Treatment of Congenital Alpha-1 Antitrypsin Deficiency

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Dicerna™ Receives Orphan Drug Designation From European Commission for DCR-A1AT for Treatment of Congenital Alpha-1 Antitrypsin Deficiency

Tue December 17, 2019 7:30 AM|Business Wire|About: DRNA

LEXINGTON, Mass.--(BUSINESS WIRE)-- Dicerna™ Pharmaceuticals, Inc. (Nasdaq: DRNA)


 https://www.businesswire.com/news/home/20191217005176/en/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial

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First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness

Mon December 16, 2019 8:05 AM|Business Wire|About: ABMD

DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed (NASDAQ: ABMD)


 http://www.abiomed.com/impella 


 https://www.impella.com/ 


 http://www.abiomed.com/ 


 https://www.businesswire.com/news/home/20191216005332/en/ 

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP)

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BioMarin Announces Positive Final Results from Placebo-Controlled Phase 3 Data in Children with Achondroplasia Treated with Vosoritide

Mon December 16, 2019 8:15 AM|PR Newswire|About: BMRN

Pre-submission Meetings with Health Authorities Planned for H1 2020 to Discuss Marketing Applications

PR Newswire

SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)


 https://www.prnewswire.com/news-releases/biomarin-announces-positive-final-results-from-placebo-controlled-phase-3-data-in-children-with-achondroplasia-treated-with-vosoritide-300975084.html 


 

BioMarin's vosoritide successful in late-stage achondroplasia study

Dec. 16, 2019 11:37 AM ET|About: BioMarin Pharmaceutica... (BMRN)|By: , SA News Editor  

 https://seekingalpha.com/news/3526501-biomarins-vosoritide-successful-in-late-stage-achondroplasia-study 


 https://investors.biomarin.com/2019-12-16-BioMarin-Announces-Positive-Final-Results-from-Placebo-Controlled-Phase-3-Data-in-Children-with-Achondroplasia-Treated-with-Vosoritide 


belantamab mafodotin (GSK2857916)

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Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma

Mon December 16, 2019 6:36 PM|Canada Newswire|About: GSK

  • Overall response rate (ORR) of 31% with 2.5 mg/kg regimen and no new safety signals in heavily pre-treated patient population who were refractory to an immunomodulatory drug and a proteasome inhibitor, and were refractory or intolerant to an anti-CD38 antibody
  • Data published in The Lancet Oncology highlight the potential of belantamab mafodotin for patients with multiple myeloma whose disease has progressed
  • GSK confirms submission of a Biologics License Application to the US Food and Drug Administration  

LONDON, Dec. 16, 2019 /CNW/ -- GlaxoSmithKline plc (GSK


 https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916 


 https://www.prnewswire.com/news-releases/pivotal-dreamm-2-study-demonstrated-a-clinically-meaningful-overall-response-rate-with-belantamab-mafodotin-gsk2857916-for-patients-with-relapsedrefractory-multiple-myeloma-300975664.html 


 

Glaxo antibody-drug conjugate shows treatment benefit in refractory MM

Dec. 17, 2019 7:16 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 

 https://seekingalpha.com/news/3526697-glaxo-antibody-drug-conjugate-shows-treatment-benefit-in-refractory-mm 


Sangamo updates on pipeline at R&D Day

 

Sangamo Highlights Advancements in Genomic Medicine Pipeline and Expanded R&D and Manufacturing Capabilities at R&D Day

Tue December 17, 2019 6:45 AM|Business Wire|About: SGMO

  • IND transfer to Pfizer for SB-525 hemophilia A gene therapy is substantially completed; Pfizer is advancing SB-525 into a Phase 3 registrational study in 2020
  • At R&D Day, Sangamo is detailing global capabilities across clinical science, operations, product development, and manufacturing
  • Company is also introducing new gene therapy and genome regulation programs for clinical development, including several addressing highly prevalent diseases, with IND targets in 2021 and 2022
  • Live webcast today at 8am Eastern Time

BRISBANE, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (SGMO)

 

Sangamo updates on pipeline at R&D Day

Dec. 17, 2019 7:39 AM ET|About: Sangamo Therapeutics, ... (SGMO)|By: , SA News Editor 

 https://seekingalpha.com/news/3526715-sangamo-updates-on-pipeline-r-and-d-day 


 https://www.sangamo.com/ 


 https://www.businesswire.com/news/home/20191217005318/en/ 


 https://investor.sangamo.com/news-releases/news-release-details/sangamo-highlights-advancements-genomic-medicine-pipeline-and 

Seeking Biotech Alpha DECEMBER 2019 Insight

VASCEPA® (ICOSAPENT ETHYL)

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Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce Cardiovascular Risk

Fri December 13, 2019 6:14 PM|PR Newswire|About: AMRN

- Millions of people in the United States qualify as treatment candidates For VASCEPA

- Cardiovascular disease events, including heart attack, stroke and cardiovascular death, occur in the United States every 14 seconds and are economically, physically and emotionally costly

- VASCEPA has been assessed by independent bodies as priced cost effectively as a cardiovascular risk reduction treatment

- VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million

Amarin to host webcast on Monday, December 16 at 7:30 a.m., Eastern Time

PR Newswire

DUBLIN and BRIDGEWATER, N.J., Dec. 13, 2019 /PRNewswire/ -- Amarin Corporation plc (AMRN)


 https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups 


 https://investor.amarincorp.com/news-releases/news-release-details/amarin-receives-fda-approval-vascepar-icosapent-ethyl-reduce 


 https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf 


 https://www.vascepa.com/ 


 https://www.prnewswire.com/news-releases/amarin-receives-fda-approval-of-vascepa-icosapent-ethyl-to-reduce-cardiovascular-risk-300974860.html 


 Home / All posts / HLS Therapeutics has a winner in Vascepa, Stifel says

HLS Therapeutics has a winner in Vascepa, Stifel says

DECEMBER 17, 2019 BY

 https://www.cantechletter.com/2019/12/hls-therapeutics-has-a-winner-in-vascepa-stifel-says/ 


EXALT™ Model D Single-Use Duodenoscope

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Boston Scientific Receives FDA Clearance For World's First Single-Use Duodenoscope, EXALT™ Model D

Fri December 13, 2019 1:30 PM|PR Newswire|About: BSXPR Newswire

MARLBOROUGH, Mass., Dec. 13, 2019 /PRNewswire/ -- Boston Scientific Corporation (BSX)


 https://www.bostonscientific.com/en-US/Home.html 


 https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-clearance-for-worlds-first-single-use-duodenoscope-exalt-model-d-300974733.html 

dispersible-tablet (DT) formulation of dolutegravir (DTG)

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13 December 2019

ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV

If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible tablet for children living with HIV - closing the gap between treatment options available for adults and children

Issued: London, UK

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited 


 

ViiV Healthcare files applications for dispersible formulations of dolutegravir

Dec. 13, 2019 6:43 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor  

 https://seekingalpha.com/news/3526102-viiv-healthcare-files-applications-for-dispersible-formulations-of-dolutegravir 


 https://www.tivicayhcp.com/ 

BTK inhibitor BRUKINSA™ (zanubrutinib)

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BeiGene Announces Results of Phase 3 ASPEN Trial of Zanubrutinib Compared to Ibrutinib for the Treatment of Patients with Waldenström’s Macroglobulinemia

Mon December 16, 2019 7:00 AM|GlobeNewswire|About: BGNE

- Primary Endpoint of Statistical Superiority Related to Deep Response (VGPR or Better) Was Not Met; However, Zanubrutinib Demonstrated More Frequent VGPRs (28.4% vs.19.2% in Overall Population)

- Zanubrutinib Demonstrated Advantages in Safety and Tolerability Compared to Ibrutinib

- ASPEN is the Largest Phase 3 Trial in Waldenström’s Macroglobulinemia and the First Comparative Trial Readout for BTK Inhibitors

- Company to Hold Investor Conference Call and Webcast Today at 8:30 AM ET

CAMBRIDGE, Mass. and BEIJING, China, Dec. 16, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE),


 http://ir.beigene.com/news-releases/news-release-details/beigene-announces-results-phase-3-aspen-trial-zanubrutinib?loc=US 


 http://hkexir.beigene.com/?loc=US 


 https://www.beigene.com/PDF/BRUKINSAUSPPI.pdf 



combination =acetyl-CoA carboxylase (ACC) inhibitor firsocostat & nonsteroidal farnesoid X receptor

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Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Mon December 16, 2019 8:00 AM|Business Wire|About: GILD

 -- Study Primary Endpoint Was Not Met; Improvement in Multiple Measures of Fibrosis and Liver Injury Was Observed with Investigational Firsocostat and Cilofexor --

-- Regimens Were Well Tolerated and Safety Measures Were Consistent with Prior Studies –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.gilead.com/ 


 https://www.businesswire.com/news/home/20191216005231/en/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

VYNDAQEL® (tafamidis 61 mg) and VYNDAQEL® (tafamidis meglumine 20 mg)

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Pfizer Receives Positive CHMP Opinion for VYNDAQEL® for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease

Fri December 13, 2019 8:28 AM|Business Wire|About: PFE

—If approved by the European Commission (EC), VYNDAQEL® will be the first pharmacologic therapy in the EU for patients with transthyretin amyloid cardiomyopathy—

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)


 https://www.businesswire.com/news/home/20191213005202/en/ 


 https://www.pfizer.com/science/drug-product-pipeline 


Tislelizumab in Combination with Sitravatinib

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BeiGene Announces Clinical Data on Investigational Anti-PD-1 Antibody Tislelizumab in Combination with Sitravatinib at European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2019

Fri December 13, 2019 7:00 AM|GlobeNewswire|About: BGNE, MRTXGlobeNewswire

CAMBRIDGE, Mass. and BEIJING, China, Dec. 13, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)


 https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab 


 http://ir.beigene.com/news-releases/news-release-details/beigene-announces-clinical-data-investigational-anti-pd-1?loc=US 


 Mirati Therapeutics (MRTX


 https://www.mirati.com/pipeline/ 


 

BeiGene's tislelizumab combo shows positive action in ovarian cancer

Dec. 13, 2019 8:25 AM ET|About: BeiGene, Ltd. (BGNE)|By: , SA News Editor  

 https://seekingalpha.com/news/3526149-beigenes-tislelizumab-combo-shows-positive-action-in-ovarian-cancer 

Jardiance® (empagliflozin)

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Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure

Fri December 13, 2019 8:00 AM|PR Newswire|About: LLY

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (LLY


 https://clinicaltrials.gov/ct2/show/NCT03448406?term=EMPERIAL&rank=1 


 https://clinicaltrials.gov/ct2/show/NCT03448419?term=EMPERIAL&rank=2 


 https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/Patient%20Info/Jardiance%20Patient%20Information.pdf?DMW_FORMAT=pdf 


 https://www.boehringer-ingelheim.us/ 


 https://www.lillydiabetes.com/ 


 https://www.lilly.com/products 


 

Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure

12/13/2019Download PDF

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)

 https://investor.lilly.com/news-releases/news-release-details/boehringer-ingelheim-and-lilly-provide-update-jardiancer-phase 

DARZALEX® (daratumumab)

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CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

Fri December 13, 2019 6:32 AM|GlobeNewswire|About: GMAB

Company Announcement

  • CHMP issued positive opinion for DARZALEX® in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
  • Final decision from European Commission expected in the coming months
  • Opinion based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; December 13, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)


 https://www.darzalex.com/ 


 http://www.genmab.com/ 


 

European advisory group backs expanded use of J&J's Darzalex

Dec. 13, 2019 7:57 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor 

 https://seekingalpha.com/news/3526131-european-advisory-group-backs-expanded-use-of-j-and-js-darzalex 



automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration

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PerkinElmer Launches First FDA-Approved Assay Kit to Screen for Duchenne Muscular Dystrophy in Newborns

Fri December 13, 2019 9:20 AM|Business Wire|About: PKI

Available on PerkinElmer’s automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration instead of CK enzyme activity

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (PKI), (NYSE: PKI)


 https://newbornscreening.perkinelmer.com/products/gsp_instrument/gsp_neonatal_creatine_kinase_-mm_kit 


 https://newbornscreening.perkinelmer.com/ 


 https://www.perkinelmer.com/ 


 https://www.businesswire.com/news/home/20191213005240/en/ 

Seeking Biotech Alpha DECEMBER 2019 Insight

TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib)

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 TECENTRIQ® (atezolizumab), COTELLIC® (cobimetinib) and ZELBORAF® (vemurafenib) are registered trademarks of Genentech, a member of the Roche Group. 

 

Exelixis Announces Positive Results From IMspire150, the Phase 3 Trial of Atezolizumab Plus Cotellic and Vemurafenib in People With Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma

Fri December 13, 2019 1:02 AM|Business Wire|About: EXEL

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL)


 https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program 


 https://www.businesswire.com/news/home/20191212005923/en/ 


 https://www.exelixis.com/ 


 https://www.exelixis.com/ 

CYRAMZA® (ramucirumab)

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CHMP Issues Positive Opinion to Expand CYRAMZA® (ramucirumab) Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Fri December 13, 2019 6:47 AM|PR Newswire|About: LLY

Positive opinion based on Phase 3 RELAY study, which showed significant improvement in progression-free survival

PR Newswire

INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://clinicaltrials.gov/ct2/show/NCT02411448 


 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30634-5/fulltext 


 http://uspl.lilly.com/cyramza/cyramza.html 


 https://www.lillyoncology.com/ 


 https://www.cyramza.com/ 


 

CHMP Issues Positive Opinion to Expand CYRAMZA® (ramucirumab) Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

12/13/2019Download PDFCYRAMZA in combination with erlotinib recommended for approval in the EU for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations
Positive opinion based on Phase 3 RELAY study, which showed significant improvement in progression-free survival

INDIANAPOLIS, Dec. 13, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

 https://investor.lilly.com/news-releases/news-release-details/chmp-issues-positive-opinion-expand-cyramzar-ramucirumab-label 

CYRAMZA is a prescription medicine used to treat certain types of cancer. It is given by intravenous (IV) infusion. An IV infusion is when a needle is placed into your vein and a medicine is given slowly. CYRAMZA is prescribed in these ways: By itself or with a chemotherapy medicine called paclitaxel to treat certain kinds of stomach cancer or cancer of the area where the stomach and esophagus (food pipe) meet that is advanced or has spread to other parts of the body. The area where the stomach and esophagus meet is often called the gastroesophageal (GE) junction. CYRAMZA is for people whose stomach cancer got worse during or after certain other types of chemotherapy. With a chemotherapy medicine called docetaxel to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has gotten worse during or after another type of chemotherapy. People who have tumors with certain abnormal genes should not receive CYRAMZA unless they have already been treated with medicine that targets those changes and their cancer became worse during treatment. With a combination of chemotherapy medicines called FOLFIRI (irinotecan, folinic acid, and fluorouracil). This is given to treat colorectal cancer (CRC) that has spread to other parts of the body and has gotten worse during or after certain other types of chemotherapy. By itself to treat a type of liver cancer called hepatocellular carcinoma (HCC). CYRAMZA is for people who have levels of alpha-fetoprotein of at least 400 nanograms per milliliter (ng/mL) in their blood and have been treated with another type of

Beovu® (brolucizumab)

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 On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Beovu, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD). The applicant for this medicinal product is Novartis Europharm Limited. 


 

European advisory group backs Novartis' brolucizumab for wet AMD

Dec. 13, 2019 7:17 AM ET|About: Novartis AG (NVS)|By: , SA News Editor 

 https://seekingalpha.com/news/3526114-european-advisory-group-backs-novartis-brolucizumab-for-wet-amd 



 BEOVU® (brolucizumab-dbll) injection is used for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD). 

 https://www.beovu.com/?utm_medium=paid&utm_term=Branded_Broad%20|%20beovu&utm_source=google&utm_campaign=Branded_Broad 

XELJANZ® XR (tofacitinib)

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FDA Approves XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

Thu December 12, 2019 5:12 PM|Business Wire|About: PFE

XELJANZ XR provides adult patients living with moderately to severely active UC the first and only once-daily JAK inhibitor for managing their disease

NEW YORK--(BUSINESS WIRE)--

Pfizer Inc. (PFE)


 https://labeling.pfizer.com/ShowLabeling.aspx?id=959 


 https://www.pfizer.com/ 


 https://www.businesswire.com/news/home/20191212005841/en/ 

 

FDA OK's extended-release Xeljanz for ulcerative colitis

Dec. 13, 2019 6:50 AM ET|About: Pfizer Inc. (PFE)|By: , SA News Editor  

 https://seekingalpha.com/news/3526105-fda-oks-extended-release-xeljanz-for-ulcerative-colitis 



VYONDYS 53™ (golodirsen) Injection

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Sarepta Therapeutics Announces FDA Approval of VYONDYS 53™ (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53

Thu December 12, 2019 6:19 PM|GlobeNewswire|About: SRPT

-- VYONDYS 53 is Sarepta’s second RNA exon-skipping treatment for DMD approved in the U.S. --

-- Commercial distribution of VYONDYS 53 in the U.S. will commence immediately --

-- Information for patients and clinicians is available at www.SareptAssist.com -- 

CAMBRIDGE, Mass., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)


 https://www.sarepta.com/our-product/sareptassist 


 https://www.vyondys53.com/Vyondys53_(golodirsen)_Prescribing_Information.pdf 


 https://www.sarepta.com/our-pipeline 



Tecentriq® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib)

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Genentech Announces Phase III Study Results for Tecentriq Plus Cotellic and Zelboraf in People With Previously Untreated BRAF V600 Mutation-positive Advanced Melanoma

Fri December 13, 2019 1:00 AM|Business Wire|About: RHHBY

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.businesswire.com/news/home/20191212005920/en/ 


 https://www.gene.com/ 


 https://www.gene.com/topics/cancer-immunotherapy 


 https://www.gene.com/patients/medicines/zelboraf 


 https://www.cotellic.com/ 




Seeking Biotech Alpha DECEMBER 2019 Insight

EVENITY® (romosozumab)

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European Commission Approves EVENITY® (romosozumab) For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture

Thu December 12, 2019 1:00 AM|PR Newswire|About: AMGN, UCBJY

Novel Bone-Builder With a Dual Effect That Increases Bone Formation and Reduces Bone Loss

PR Newswire

THOUSAND OAKS, Calif. and BRUSSELS, Dec. 11, 2019 /PRNewswire/ -- Amgen (AMGN) and UCB (Euronext Brussels: UCB)


 https://www.prnewswire.com/news-releases/european-commission-approves-evenity-romosozumab-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture-300973794.html 


 https://www.amgen.com/ 


 https://www.amgen.com/media/news-releases/2019/12/european-commission-approves-evenity-romosozumab-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture/ 


KEYTRUDA® (pembrolizumab)

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Data from Exploratory Analysis Show Merck’s KEYTRUDA® (pembrolizumab) Improved Overall Survival as Monotherapy for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer Regardless of KRAS Mutational Status

Thu December 12, 2019 6:45 AM|Business Wire|About: MRK

New Findings from Phase 3 KEYNOTE-042 Study Were Presented Today at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2019

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada


 https://www.merck.com/clinical-trials/index.html 


 https://www.merck.com/index.html 


 https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 


 https://www.businesswire.com/news/home/20191212005312/en/ 


 https://seekingalpha.com/news/3525781-mercks-keytruda-extends-survival-in-first-line-lung-cancer 


 https://www.keytruda.com/ 

Imfinzi (durvalumab)

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Imfinzi approved in China for the treatment of unresectable, Stage III non-small cell lung cancer based on the Phase III PACIFIC trial

PUBLISHED12 December 2019

12 December 2019 07:00 GMT
 

Imfinzi is the only immunotherapy approved in China to treat patients
in the curative-intent Stage III setting following chemoradiation treatment
 

 https://seekingalpha.com/news/3525759-astrazenecas-imfinzi-okd-in-china-for-lung-cancer 

Kymriah® (tisagenlecleucel)

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Novartis completes certification of initial sites in Ontario for first approved Canadian CAR-T therapy, Kymriah® (tisagenlecleucel)

Thu December 12, 2019 7:00 AM|Canada Newswire

  • Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada is now available in Ontario to treat certain Canadian patients with relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL
  • Ontario government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical need

DORVAL, QC, Dec. 12, 2019 /CNW/ - Novartis Pharmaceuticals Canada Inc


 https://www.novartis.ca/en 


 https://www.novartis.com/ 


 https://www.cancercareontario.ca/en/guidelines-advice/types-of-cancer/hematologic/car-t-cell-therapy-enrolment 


 https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/# 


 https://www.us.kymriah.com/acute-lymphoblastic-leukemia-children/ 


 https://seekingalpha.com/news/3525812-novartis-completes-certification-of-initial-sites-in-ontario-for-kymriah 

Investigational KTE-X19

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Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy

Wed December 11, 2019 4:05 PM|Business Wire|About: GILD

-- Investigational KTE-X19 To Be First Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma if Approved --

-- Filing for Kite’s Second CAR T Therapy Marks Potential Expansion of Company’s Cell Therapy Portfolio --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)


 https://www.kitepharma.com/ 


 https://www.businesswire.com/news/home/20191211005861/en/ 


 

Gilead files U.S. application for CAR T for mantle cell lymphoma

Dec. 11, 2019 4:20 PM ET|About: Gilead Sciences, Inc. (GILD)|By: , SA News Editor 

 https://seekingalpha.com/news/3525673-gilead-files-u-s-application-for-car-t-for-mantle-cell-lymphoma 


Seeking Biotech Alpha DECEMBER 2019 Insight

LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292

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Lilly Opens First Ever Randomized Phase 3 Clinical Trial in Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

Wed December 11, 2019 6:45 AM|PR Newswire|About: LLY

- Trial aims to enroll 400 patients with advanced or metastatic treatment-naïve RET fusion-positive NSCLC

PR Newswire

INDIANAPOLIS, Dec. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.lillyoncology.com/ 


 https://www.lilly.com/ 


 https://www.prnewswire.com/news-releases/lilly-opens-first-ever-randomized-phase-3-clinical-trial-in-treatment-naive-ret-fusion-positive-non-small-cell-lung-cancer-300972812.html 

[fam]-trastuzumab deruxtecan (DS-8201)

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[Fam]-Trastuzumab Deruxtecan Achieved a Tumor Response of 60.9% in Pivotal Phase II HER2-positive Metastatic Breast Cancer Trial

Wed December 11, 2019 8:00 AM|Business Wire|About: AZN

AstraZeneca and Daiichi Sankyo’s [fam]-trastuzumab deruxtecan demonstrated an impressive 14.8-month median duration of response and 16.4-month median progression-free survival

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Daiichi Sankyo Company, Limited (Daiichi Sankyo)


 https://www.businesswire.com/news/home/20191211005425/en/ 


 

AstraZeneca/Daiichi ADC shows sustained benefit in mid-stage breast cancer study

Dec. 11, 2019 9:19 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor 

 https://seekingalpha.com/news/3525505-astrazeneca-daiichi-adc-shows-sustained-benefit-in-mid-stage-breast-cancer-study 

mavrilimumab, in combination with Yescarta® (axicabtagene ciloleucel)

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Kite and Kiniksa Pharmaceuticals Announce Clinical Collaboration Evaluating Investigational Combination of Yescarta® and Mavrilimumab in Relapsed or Refractory Large B-Cell Lymphoma

Wed December 11, 2019 8:30 AM|Business Wire|About: GILD, KNSA

-- Phase 2 study will Examine the Effect of Mavrilimumab on the Clinical Profile of Yescarta --

SANTA MONICA, Calif., & HAMILTON, Bermuda--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), and Kiniksa Pharmaceuticals, Ltd. (KNSA)


 https://www.kiniksa.com/our-pipeline/ 


 https://www.businesswire.com/news/home/20191211005149/en/ 


 mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in combination with Yescarta® (axicabtagene ciloleucel) 


 https://www.yescartarems.com/ 


 https://www.kitepharma.com/ 


 https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-and-kiniksa-pharmaceuticals-announce-clinical-collaboration-evaluating-investigational-combination-of-yescarta-and-mavrilimumab-in-relapsed-or-r 


 https://www.kiniksa.com/ 



Xolair® (omalizumab)

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FDA Accepts Supplemental Biologics License Application for Xolair (omalizumab) for the Treatment of Nasal Polyps

Wed December 11, 2019 1:00 AM|Business Wire|About: RHHBY

– The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids –

– If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E –

– Frequently co-occurring with other respiratory conditions, nasal polyps is a chronic condition and causes a range of symptoms impacting patients’ lives including loss of sense of smell and nasal congestion –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.xolair.com/?cid=gne_WE_00000083 


 https://www.gene.com/ 

 https://www.businesswire.com/news/home/20191210006130/en/ 


 https://seekingalpha.com/news/3525421-fda-accepts-genentechs-sbla-for-xolair 


 https://www.gene.com/media/press-releases/14830/2019-12-10/fda-accepts-supplemental-biologics-licen 


Seeking Biotech Alpha DECEMBER 2019 Insight

EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34

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Editas Medicine Announces In Vivo Proof-of-Concept Data for EDIT-301, in Development for the Treatment of Sickle Cell Disease and Beta-Thalassemia

Mon December 9, 2019 6:00 PM|GlobeNewswire|About: EDITGlobeNewswire

CAMBRIDGE, Mass., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (EDIT)


 https://www.editasmedicine.com/ 



Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

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Amgen Data From Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) To Be Presented During Late-Breaking Session At American Society Of Hematology Annual Meeting

Tue December 10, 2019 7:30 AM|PR Newswire|About: AMGN

37% Reduction in the Risk of Progression or Death Compared to KYPROLIS and Dexamethasone (Kd) in Patients With Relapsed/Refractory Multiple Myeloma

Patients Treated With KdD Achieved Deeper Responses Than Patients Treated With Kd Alone

PR Newswire

THOUSAND OAKS, Calif., Dec. 10, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.darzalex.com/newly-diagnosed-multiple-myeloma#banner-click 


 https://www.prnewswire.com/news-releases/amgen-data-from-phase-3-candor-study-combining-kyprolis-carfilzomib-and-darzalex-daratumumab-to-be-presented-during-late-breaking-session-at-american-society-of-hematology-annual-meeting-300971947.html 

Kalydeco (ivacaftor)

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EC OKs expanded label for Vertex's Kalydeco

Dec. 10, 2019 7:34 AM ET|About: Vertex Pharmaceuticals... (VRTX)|By: , SA News Editor  


 

Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) in Infants With Cystic Fibrosis Ages 6 Months to Less Than 12 Months With Certain Mutations in the CFTR Gene

- Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in children this young -

 https://www.streetaccount.com/pressrelease.aspx?ticker=VRTX&intraday_id=2692641 

(bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺)

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XBiotech Announces Agreement to Sell True Human Antibody Bermekimab Targeting IL-1a to Janssen

Sat December 7, 2019 3:05 AM|GlobeNewswire|About: XBITGlobeNewswire

AUSTIN, Texas, Dec. 07, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT)


 https://seekingalpha.com/news/3524623-xbiotech-out-licenses-anti-inflammatory-antibody-to-janssen-for-up-to-1_35b 


 https://clinicaltrials.gov/ct2/show/NCT03496974 


 http://www.xbiotech.com/ 




Seeking Biotech Alpha DECEMBER 2019 Insight

IL-15 Agonist, NKTR-255

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Nektar Therapeutics Announces Presentation of New Preclinical Data for its IL-15 Agonist, NKTR-255, at the American Society of Hematology (ASH) 2019 Annual Meeting

Mon December 9, 2019 10:05 AM|PR Newswire|About: NKTR

SAN FRANCISCO, Dec. 9, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR)


 https://www.nektar.com/science/scientific-posters 


 https://www.nektar.com/ 


 https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-presentation-of-new-preclinical-data-for-its-il-15-agonist-nktr-255-at-the-american-society-of-hematology-ash-2019-annual-meeting-300971422.html 

LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel)

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bluebird bio Presents New Data Demonstrating Long-Term Transfusion Independence and Safety for LentiGlobin™ Gene Therapy for β-thalassemia (betibeglogene autotemcel) at 61st ASH Annual Meeting and Exposition

Mon December 9, 2019 4:30 PM|Business Wire|About: BLUE 


 https://www.bluebirdbio.com/our-science/pipeline 


 https://www.businesswire.com/news/home/20191209005708/en/ 

Reblozyl® (luspatercept-aamt)

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Reblozyl® (luspatercept-aamt) Studies Evaluating Treatment of Anemia in Rare Blood Diseases Presented at American Society of Hematology (ASH) Annual Meeting

Mon December 9, 2019 4:30 PM|Business Wire|About: BMY, XLRN

Initial results from phase 2 study evaluating an investigational use of luspatercept-aamt in myelofibrosis-associated anemia showed promising clinical activity – companies plan to initiate pivotal, phase 3 study called INDEPENDENCE in 2020

Longer-term follow-up from pivotal phase 3 studies of MEDALIST in MDS-associated anemia and BELIEVE in beta thalassemia-associated anemia showed patients experiencing sustained clinical benefit

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and Acceleron Pharma (XLRN


 https://media.celgene.com/content/uploads/reblozyl-pi.pdf 


 http://acceleronpharma.com/ 


 https://www.businesswire.com/news/home/20191209005174/en/ 

bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy

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bluebird bio and Bristol-Myers Squibb Present Updated Data from Ongoing Phase 1 Study of BCMA-Targeted CAR T Cell Therapy bb21217 in Relapsed/Refractory Multiple Myeloma at 61st ASH Annual Meeting and Exposition

Mon December 9, 2019 6:15 PM|Business Wire|About: BLUE, BMY

Safety profile consistent with known toxicities of CAR T therapies

CAR T persistence observed in 8/10 evaluable responders at Month 6 and 2/2 evaluable responders at Month 18

CAMBRIDGE, Mass., & PRINCETON, N.J.--(BUSINESS WIRE)--

bluebird bio, Inc. (Nasdaq: BLUE) and Bristol-Myers Squibb (BMY) (NYSE: BMY)


 bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy  

 clinicaltrials.gov using identifier NCT03274219. 


 https://www.bluebirdbio.com/our-science/pipeline 


 https://www.businesswire.com/news/home/20191209005754/en/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

BRUKINSA™ (Zanubrutinib)

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BeiGene Announces Clinical Data on BRUKINSA™ (Zanubrutinib) at the 61st American Society of Hematology (ASH) Annual Meeting

Sun December 8, 2019 4:45 PM|GlobeNewswire|About: BGNE

Oral presentations on data from two clinical trials in chronic lymphocytic leukemia or small lymphocytic lymphoma

Poster presentation on data from clinical trial of BRUKINSA combined with tislelizumab in B-cell malignancies

CAMBRIDGE, Mass. and BEIJING, China, Dec. 08, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)


 https://www.beigene.com/PDF/BRUKINSAUSPI.pdf 


 https://www.beigene.com/products 



ADCETRIS® (Brentuximab Vedotin)

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Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

Mon December 9, 2019 10:00 AM|Business Wire|About: SGEN, TAK

- Four-Year Data Continue to Show Superior Progression-Free Survival of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma with 31 Percent Reduction in the Risk of Progression or Death -

- Additional Analysis from ECHELON-2 Phase 3 Clinical Trial Evaluating ADCETRIS Plus CHP Chemotherapy Also Featured at ASH Annual Meeting -

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)


 https://www.seattlegenetics.com/products/adcetris-us 


 https://www.takeda.com/newsroom/newsreleases/2019/seattle-genetics-and-takeda-announce-additional-analyses-of-adcetris-brentuximab-vedotin-echelon-1-and-echelon-2-phase-3-clinical-trials-at-the-2019-ash-annual-meeting/ 


 https://www.seattlegenetics.com/ 


 https://www.businesswire.com/news/home/20191209005142/en/ 


Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

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Amgen Selects Location For R&D Facility In The South San Francisco Biotechnology Hub

Mon December 9, 2019 9:00 AM|PR Newswire|About: AMGN

New Location Will Strengthen R&D Presence in South San Francisco and Provide Flexibility for Future Growth

PR Newswire

THOUSAND OAKS, Calif., Dec. 9, 2019 /PRNewswire/ -- Amgen (AMGN) today announced the signing of a lease with BioMed Realty (BMR)


 https://www.prnewswire.com/news-releases/amgen-selects-location-for-rd-facility-in-the-south-san-francisco-biotechnology-hub-300971372.html 


Flublok® Quadrivalent (Influenza Vaccine)

image192

 

Sanofi awarded $226 million by US government to expand pandemic influenza preparedness

Mon December 9, 2019 8:30 AM|PR Newswire|About: SNYPR Newswire

SWIFTWATER, Pa., Dec. 9, 2019 /PRNewswire/ -- Sanofi Pasteur, the vaccines global business unit of Sanofi (SNY)


 https://www.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf 


 https://www.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf 


 https://www.prnewswire.com/news-releases/sanofi-awarded-226-million-by-us-government-to-expand-pandemic-influenza-preparedness-300971002.html 



ADYNOVATE ® [Antihemophilic Factor (Recombinant), PEGylated] & FEIBA® [Anti-Inhibitor Coagulant Comp

image193



 h

Takeda Demonstrates Its Long-Standing Commitment to Advancing Treatments for Rare Bleeding Disorders with Studies Highlighting Real-World Evidence and Investigational Gene Therapy at ASH 2019

Mon December 9, 2019 10:00 AM|Business Wire|About: TAK

- Key learnings from real-world data are applied as Takeda (TKPHF) continues to evolve its hematology portfolio, advancing treatment for the bleeding disorders community

- Pre-clinical scientific studies demonstrate potential opportunities to improve upon adeno-associated virus gene therapies for hemophilia and other monogenic diseases

OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“Takeda”),


 https://www.shirecontent.com/PI/PDFs/ADYNOVATE_USA_ENG.pdf 


 https://www.shirecontent.com/PI/PDFs/FEIBA_USA_ENG.pdf 


 https://www.hemophilia.org/Bleeding-Disorders/Future-Therapies 


 https://www.businesswire.com/news/home/20191209005481/en/ 




Seeking Biotech Alpha DECEMBER 2019 Insight

lisocabtagene maraleucel (liso-cel), an investigational CD19-directed CAR T-cell therapy

image199

 

Bristol-Myers Squibb Announces Studies Evaluating liso-cel in Multiple Additional Patient Populations, Site of Care and Disease Areas Presented at American Society of Hematology (ASH) Annual Meeting

Sun December 8, 2019 4:30 PM|Business Wire|About: BMY

Heavily pre-treated patients with chronic lymphocytic leukemia receiving liso-cel achieved durable complete responses, including undetectable minimal residual disease

Preliminary data from the PILOT study showed promising efficacy and safety as second-line therapy in patients with aggressive relapsed or refractory large B-cell non-Hodgkin lymphoma who were transplant ineligible

Separate analysis of patients treated in the outpatient setting across three studies also presented

PRINCETON, N.J.--(BUSINESS WIRE)--

Bristol-Myers Squibb Company (BMY) (NYSE: BMY)


 https://www.businesswire.com/news/home/20191208005049/en/ 



Seeking Biotech Alpha DECEMBER 2019 Insight

lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy

image201

 

Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study

Sat December 7, 2019 2:00 PM|Business Wire|About: BMY

Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses

Generally manageable safety profile with low incidence of CAR T-related severe cytokine release syndrome (CRS) and neurologic events

Data presented at 2019 American Society of Hematology (ASH) Annual Meeting

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://www.businesswire.com/news/home/20191207005032/en/ 



Yescarta® (axicabtagene ciloleucel)

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Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment

Sat December 7, 2019 2:00 PM|Business Wire|About: GILD

-- 47 Percent of Refractory Large B-cell Lymphoma Patients in ZUMA-1 Pivotal Phase 2 Cohorts Were Alive Three Years after a Single Infusion of Yescarta --

-- Separate Cohort Finds Earlier Steroid Use May Reduce Risk of Severe Cytokine Release Syndrome and Neurologic Events --

ORLANDO, Fla.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD),


 https://www.businesswire.com/news/home/20191207005016/en/ 


 https://www.gilead.com/science-and-medicine/pipeline 


 YESCARTA is the first CAR T therapy for adults living with certain types of non-Hodgkin lymphoma. YESCARTA is different from other cancer treatments because it is made from your own white blood cells, which have been modified to recognize and destroy cancer cells. 

 https://getstartedwithyescarta.com/ 

Seeking Biotech Alpha DECEMBER 2019 Insight

investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB

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Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas

Sat December 7, 2019 9:00 AM|Business Wire|About: RHHBY

– Mosunetuzumab data to be presented at the American Society of Hematology 2019 Annual Meeting Plenary Scientific Session demonstrate durable complete responses in people with relapsed or refractory non-Hodgkin’s lymphoma –

– Preliminary safety and efficacy data for CD20-TCB support potential of combination approaches with anti-CD20 therapies –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.gazyva.com/ 


 https://www.businesswire.com/news/home/20191207005029/en/ 


 https://seekingalpha.com/pr/17721334-genentech-announces-new-data-on-novel-cd20-cd3-bispecific-cancer-immunotherapies-in-people 


 https://www.gene.com/ 


 https://seekingalpha.com/news/3524627-bluebird-bios-lentiglobin-gene-therapy-shows-significant-effect-in-scd-study 

ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab)

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Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

Sat December 7, 2019 2:00 PM|Business Wire|About: SGEN

- Additional Analysis in Phase 2 Trial of ADCETRIS plus OPDIVO in Patients with Frontline Hodgkin Lymphoma Aged 60 Years and Older -

- Two-Year Follow-up Results from Phase 1/2 Trial in Relapsed Hodgkin Lymphoma -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)


 https://www.businesswire.com/news/home/20191207005021/en/ 


 https://www.seattlegenetics.com/ 


 https://www.adcetris.com/ 




HGB-206 Study of LentiGlobin™ Gene Therapy

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bluebird bio Presents New Data from Ongoing Phase 1/2 HGB-206 Study of LentiGlobin™ Gene Therapy for Sickle Cell Disease (SCD) at 61st ASH Annual Meeting and Exposition

Sat December 7, 2019 2:00 PM|Business Wire|About: BLUE 

 CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (BLUE)  


 https://www.bluebirdbio.com/ 


 https://www.businesswire.com/news/home/20191207005044/en/ 


XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor

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Xenon Pharmaceuticals Provides Updates on Partnered Neurology Pipeline Programs at the 2019 American Epilepsy Society (AES) Annual Meeting

Sat December 7, 2019 8:45 AM|GlobeNewswire|About: NBIX, XENE

Overview of Clinical Stage XEN901 and Related Patient Survey to be Presented in the “Genetic Epilepsies – Updates in the Science and Diagnosis” Exhibit in Room 318-319 on Sunday, December 8th

Pre-Clinical Work Suggests Selective Sodium Channel Inhibitors that Reduce Action Potential Firing in Excitatory Neurons, While Sparing Inhibitory Interneurons, May Provide Promising Drug Profile

BURNABY, British Columbia, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (XENE)


 https://www.xenon-pharma.com/product-pipeline/xen901-for-epilepsy/ 


IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

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Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Sat December 7, 2019 7:33 AM|PR Newswire|About: ABBV

- New integrated analysis of up to six years of follow-up from RESONATE™ and RESONATE-2 studies (abstract #3054) demonstrated improved results with earlier IMBRUVICA use in CLL patients new to treatment

- Data featured at the 2019 American Society of Hematology (ASH) Annual Meeting further supports IMBRUVICA as the most comprehensively studied Bruton's tyrosine kinase inhibitor, with 10 FDA approvals and 170,000 patients treated worldwide

PR Newswire

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.prnewswire.com/news-releases/extended-follow-up-phase-3-data-underscore-sustained-efficacy-and-safety-of-imbruvica-ibrutinib-in-the-treatment-of-chronic-lymphocytic-leukemia-cll-300970876.html 


 https://imbruvica.com/ 



IMBRUVICA® (ibrutinib)

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 December 7, 2019

More than Seven-Year Analysis of Early Treatment with IMBRUVICA® (ibrutinib) Monotherapy Showed Improved Progression-Free Survival in Patients with Mantle Cell Lymphoma (MCL) that Relapsed or Were Unresponsive to Prior Regimen

 - With extended follow-up of up to 7.5 years, treatment with IMBRUVICA early on in therapy demonstrated higher rates of progression-free survival and complete response
- MCL is an aggressive B-cell malignancy in which most patients have poor prognosis and are likely to relapse after their initial treatment
- The updated pooled analysis, which represents the longest follow-up to date for a Bruton's Tyrosine Kinase inhibitor in relapsed/refractory MCL, were presented at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #1538)

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), 


 https://imbruvica.com/ .


 https://seekingalpha.com/pr/17721336-seven-year-analysis-of-early-treatment-imbruvica-ibrutinib-monotherapy-showed-improved 


 https://www.abbvie.com/our-science/pipeline.html 


 https://www.prnewswire.com/news-releases/more-than-seven-year-analysis-of-early-treatment-with-imbruvica-ibrutinib-monotherapy-showed-improved-progression-free-survival-in-patients-with-mantle-cell-lymphoma-mcl-that-relapsed-or-were-unresponsive-to-prior-regimen-300970887.html 

Seeking Biotech Alpha DECEMBER 2019 Insight

Reblozyl® (luspatercept-aamt)

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Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt)

CATEGORY: 

CORPORATE/FINANCIAL NEWSFRIDAY, DECEMBER 6, 2019 12:05 PM EST

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN)


 http://acceleronpharma.com/ 


 

Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt)

Fri December 6, 2019 12:05 PM|Business Wire|About: BMY, XLRN 

 https://seekingalpha.com/pr/17721059-bristol-myers-squibb-and-acceleron-pharma-provide-update-on-fda-advisory-committee-for 


 https://www.bms.com/media/press-releases.html 

idecabtagene vicleucel (ide-cel; bb2121)

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Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from the Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma

Fri December 6, 2019 4:16 PM|Business Wire|About: BLUE, BMY

Study met its primary endpoint and key secondary endpoint, demonstrating deep and durable responses in a heavily pre-treated multiple myeloma patient population

Safety results are consistent with the data presented in CRB-401 study

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)


 https://www.bms.com/ 


 https://www.bluebirdbio.com/our-focus 


 https://www.businesswire.com/news/home/20191206005463/en/ 



CALQUENCE® (acalabrutinib) combined with obinutuzumab

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CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia

Sat December 7, 2019 7:50 AM|Business Wire|About: AZN

Full results from Phase III ELEVATE TN trial showed 93% of patients on CALQUENCE combined with obinutuzumab vs. 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months

Trial also showed 87% of patients on CALQUENCE alone remained free of disease progression or death at 24 months

WILMINGTON, Del.--(BUSINESS WIRE)-


 https://www.azpicentral.com/calquence/calquence.pdf#page=1 


 https://www.businesswire.com/news/home/20191207005030/en/ 


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/calquence-significantly-prolonged-the-time-patients-lived-without-disease-progression-or-death-in-previously-untreated-chronic-lymphocytic-leukemia-12072019.html 

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax)

 

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

Sat December 7, 2019 7:30 AM|PR Newswire|About: ABBV

- Data will be presented at an oral presentation session at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #35)

PR Newswire

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html 


 https://www.prnewswire.com/news-releases/imbruvica-ibrutinib-plus-venclextavenclyxto-venetoclax-combination-data-show-high-rates-of-disease-clearance-in-previously-untreated-patients-with-chronic-lymphocytic-leukemia-cll-300970907.html 


 https://imbruvica.com/ 


 https://www.venclexta.com/?c=ABV_ppc_ppd_cll_br_ggl_5612&cpcd=gdc-1684e83d0eb 


 https://news.abbvie.com/news/press-releases/imbruvica-ibrutinib-plus-venclextavenclyxto-venetoclax-combination-data-show-high-rates-disease-clearance-in-previously-untreated-patients-with-chronic-lymphocytic-leukemia-cll.htm 


Seeking Biotech Alpha DECEMBER 2019 Insight

cobas vivoDx MRSA diagnostic test to detect methicillin-resistant Staphylococcus aureus (MRSA)

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FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

 For Immediate Release:

December 05, 2019 


 

FDA OKs new MRSA test from Roche

Dec. 5, 2019 12:44 PM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  

Pimavanserin is a selective serotonin inverse agonist & antagonist targeting 5-HT2A receptors.

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ACADIA Pharmaceuticals Presents Positive Top-line Results from Pivotal Phase 3 HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis at 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting

Wed December 4, 2019 8:45 PM|Business Wire|About: ACAD

- Pimavanserin met the primary endpoint in the study, significantly reducing the risk of relapse of psychosis by 2.8 fold (Hazard Ratio (HR)=0.353, one-sided p=0.0023)

- Pimavanserin met the key secondary endpoint in the study, significantly reducing the risk of discontinuation for any reason by 2.2 fold (HR=0.452, one-sided p=0.0024)

- Currently, there is no FDA-approved drug for the treatment of dementia-related psychosis

- Webcast to be held today at 7:15 p.m. Pacific Time

SAN DIEGO--(BUSINESS WIRE)-- ACADIA Pharmaceuticals Inc. (ACAD)


 https://seekingalpha.com/news/3524051-acadia-pharma-up-16-on-pimavanserin-data-in-dementia-psychosis 


 https://www.businesswire.com/news/home/20191204005956/en/ 


 https://www.acadia-pharm.com/pipeline/pimavanserin-drp/ 


 https://www.acadia-pharm.com/pipeline/ 



Aducanumab

 

Biogen Inc. (BIIB) Aducanumab Phase 3 Topline Results Conference (Transcript)

Dec. 5, 2019 6:29 PM ET|2 comments  | About: Biogen Inc. (BIIB) 


 https://www.biogen.com/en_us/pipeline.html 


 http://investors.biogen.com/static-files/ddd45672-9c7e-4c99-8a06-3b557697c06f